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Internet-based Treatment of Generalized Anxiety Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Umeå University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01570374
First received: March 31, 2012
Last updated: April 3, 2012
Last verified: March 2012

March 31, 2012
April 3, 2012
January 2012
January 2013   (final data collection date for primary outcome measure)
  • Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Measures anxiety symtoms related to Generalized Anxiety Disorder. 16 items.
  • Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measures anxiety symtoms related to Generalized Anxiety Disorder. 16 items.
  • Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measures anxiety symtoms related to Generalized Anxiety Disorder. 16 items.
  • Change from baseline in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Measures anxiety symtoms related to Generalized Anxiety Disorder. 16 items.
Same as current
Complete list of historical versions of study NCT01570374 on ClinicalTrials.gov Archive Site
  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    21 item rating scale for anxiety symptoms.
  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    21 item rating scale for anxiety symptoms.
  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    21 item rating scale for anxiety symptoms.
  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    21 item rating scale for anxiety symptoms.
  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    9-item depression rating scale.
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.
  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: Weekly during treatment period ] [ Designated as safety issue: No ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Weekly during treatment period ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
Same as current
Not Provided
Not Provided
 
Internet-based Treatment of Generalized Anxiety Disorder
Internet-based Treatment of Generalized Anxiety Disorder

The purpose of this study is to determine whether internet-administered cognitive behavior therapy is a feasible treatment for generalized anxiety disorder.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Generalized Anxiety Disorder
Behavioral: Internet-based cognitive behavioral therapy (iCBT)
9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.
  • Experimental: iCBT
    Receives treatment.
    Intervention: Behavioral: Internet-based cognitive behavioral therapy (iCBT)
  • No Intervention: Waiting list control group
    The waiting list control group initially receives no treatment, but do weekly screenings. After 9 weeks, the control group receives the same treatment as the other study arm.
    Intervention: Behavioral: Internet-based cognitive behavioral therapy (iCBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
January 2014
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Satisfy DSM-IV criteria for generalized anxiety disorder
  • Living in Sweden and being able to read Swedish
  • Access to computer with internet connection

Exclusion Criteria:

  • Currently receiving other psychological treatment
  • Non-stable use of psychoactive medication
  • Deemed suicidal
  • Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
Both
18 Years and older
No
Contact: Per Carlbring, Professor +46 90-786 78 33 per.carlbring@psy.umu.se
Sweden
 
NCT01570374
Oroshjalpen
No
Per Carlbring, PhD, Umeå University
Umeå University
Not Provided
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
Umeå University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP